Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy

Phase 2

Terminated

• Conditions: Ovarian Carcinoma
• Interventions: Drug: Cytophosphan, Celecoxib, Methotrexate

• Registration Number: NCT01175772
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Preclinical studies showed that metronomic chemotherapy can induce tumor regression secondary to apoptosis of the tumor blood vessels. This effect was increased by combining metronomic chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already proved clinical effects too, especially on patients with breast or prostate carcinoma. This study is aimed to test the efficacy of an experimental metronomic chemotherapy regimen in a cohort of patients with ovarian cancer. Patients will receive the proposed regimen as maintenance treatment following response induction by the conventional maximal tolerated dose (MTD) regimen of Carboplatin and Paclitaxel. Our regimen will include Cytophosphan combined with two agents which are expected to act as indirect angiogenic inhibitors: (a) celecoxib, as a selective COX-2 inhibitor and (b) low-dose Methotrexate, as successfully practiced for suppressing the inflammatory manifestations of rheumatoid arthritis. All components of our regimen will be administered orally and continuously for one year based on the hypothesis that its anti-angiogenic properties will be able to suppress the recovery of residual disease, thus extending the time to progression (TTP), and possibly the overall survival as well.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-01
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

1. Histologic proof of papillary-serous ovarian cancer or 1ary peritoneal carcinomatosis.
2. Histological grade III.
3. Original disease in stage III.
4. ECOG performance status: 0-2.
5. Age: 20-80 years.
6. Previous chemotherapy with paclitaxel and carboplatin (only).
7. Previous cyto-reductive surgery.
8. Clinical Complete Response (both physically and by imaging).
9. CA 125 should be either normalized (in at least 50 patients) or while still in decreasing values at monthly measurements.
10. CBC at normal values or with any toxicity at a grade limited to I by NCIC-CTC.
11. Liver and renal functions < 1.5 upper normal limits (UNL) by SMA.
12. The patient's signature on the informed consent.

Exclusion Criteria

1. Mucinous type ovarian carcinoma.
2. Histological Grade I-II.
3. Current continuous treatment by steroids or by NSAIDs, or by anti-coagulants for "non protocol" reasons.
4. Previous history of active peptic ulcer.
5. Current participation in any other treatment study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metronomic Chemoterapy	Cytophosphan, Celecoxib, Methotrexate	Maintenance Treatment for Ovary Carcinoma by Metronomic Chemotherapy

Primary Outcome Measures

Name	Time	Method
Time to Progression	18 months	Median time to progression of the cohort will be compared with equivalent measure in the literature.

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel